FDA.reportPublic FDA data

Tapered Drill

Primary DI
08800076422858
Brand
Tapered Drill
Company
Truabutment Korea Co.,Ltd
Model
TGTD3510
Published
2025-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076422858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076422858088000764228588800076422858

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694514760
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800076476271T-Marker KitTMK-AT-DEMO2026-07-27
08800076417960Removal DriverRDR20S2026-03-19
08800076422872Tapered DrillTGTD35142025-12-23
08800076422889Tapered DrillTGTD42062025-12-23
08800076422902Tapered DrillTGTD42102025-12-23
08800076422919Tapered DrillTGTD42122025-12-23
08800076422926Tapered DrillTGTD42142025-12-23
08800076422735Tapered DrillTGTD22062025-12-16
08800076422742Tapered DrillTGTD22082025-12-16
08800076422759Tapered DrillTGTD22102025-12-16
08800076422766Tapered DrillTGTD22122025-12-16
08800076422773Tapered DrillTGTD22142025-12-16
08800076422780Tapered DrillTGTD28062025-12-16
08800076422797Tapered DrillTGTD28082025-12-16
08800076422803Tapered DrillTGTD28102025-12-16
08800076422810Tapered DrillTGTD28122025-12-16
08800076422827Tapered DrillTGTD28142025-12-16
08800076422834Tapered DrillTGTD35062025-12-16
08800076422841Tapered DrillTGTD35082025-12-16
08800076422865Tapered DrillTGTD35122025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
06942686761223DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761230DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761247DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761254DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761261DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761278DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761285DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761292DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761308DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761315DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761322DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761339DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761346DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761353DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761360DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761377DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761384DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761391DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761407DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761414DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761421DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761438DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761445DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761452DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761469DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761476DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21